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Differin Gel

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Pharmacy Only: Prescription

Updated on 09 April 2024

File name

ie-mockup-leaflet.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

Ecipient 'Carbomer 940' updated to 'Carbomer'

Updated on 09 April 2024

File name

ie-spc-clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC uploaded on 08-04-2024 was missing revision date

Updated on 08 April 2024

File name

ie-spc-clean.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Exciepient name updated from 'Carbomer 940' to 'Carbomer'

Updated on 11 November 2022

File name

(020821) P27722-4 DIFFERIN GEL 30 IRL LEAFLET (1).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 November 2022

File name

ie-spc-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 24 February 2022

File name

(020821) P27722-3 DIFFERIN GEL 30 IRL LEAFLET.pdf

Reasons for updating

  • XPIL Updated

Updated on 20 September 2021

File name

ie-spc-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Adapalene 0.1% w/w

Excipients with known effect:

One gram of gel contains 40mg of Propylene glycol (E1520)

4.4       Special warnings and precautions for use

This medicine contains 40mg propylene glycol (E1520) in each gram which is equivalent to 4% w/w. It may cause skin irritation. This medicine also contains The excipient propylene glycol (E1520) may cause skin irritation and methyl parahydroxybenzoate (E218).  It may cause allergic reactions which can possibly be delayed.

 

10.       DATE OF REVISION OF THE TEXT

 

March 202130th September 201915 September 2021

Updated on 20 September 2021

File name

(020821) P27722-3 DIFFERIN GEL 30 IRL LEAFLET.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Differin contains:

  • 40mg of propylene glycol (E1520) in each gram which is equivalent to 4% w/w, it may cause skin irritationpropylene glycol (El 520) which may cause skin irritation

This leaflet was last revised in 037/20219

Updated on 20 September 2021

File name

ie-spc-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipients with known effect:

One gram of gel contains 40mg of Propylene glycol (E1520)

4.4       Special warnings and precautions for use

This medicine contains 40mg propylene glycol (E1520) in each gram which is equivalent to 4% w/w. It may cause skin irritation. This medicine also contains The excipient propylene glycol (E1520) may cause skin irritation and methyl parahydroxybenzoate (E218).  It may cause allergic reactions which can possibly be delayed.

 

10.       DATE OF REVISION OF THE TEXT

 

March 202130th September 201916 September 2021

Updated on 12 June 2020

File name

Differin gel 30g PIL IRE V11 (P27722-2).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Free text change information supplied by the pharmaceutical company

Change to MAH and MA number.

Updated on 09 February 2020

File name

ie-spc-current-DifferinGel-Sep19.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 24 October 2018

File name

Differin gel 30g PIL IRE V10 (P27722-1) emc.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 24 October 2018

File name

Differin Gel IRE SPC V21.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 December 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Clarification regarding use after irritation, Rewording of warning regarding use on nostrils, Addition of warnings regarding use on sunburnt skin and to minimise exposure to sunlight during use

Section 4.8 - Reorganised ADRs according to SOC

Section 10 - Update revision of text date

Updated on 04 December 2017

File name

PIL_7862_577.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 November 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Administrative changes to bring SPC in line with new EU requirements.

Updated on 23 October 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 13 August 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 22 September 2009

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.6, The pregnancy warnings have been updated.

Updated on 24 June 2009

Reasons for updating

  • Improved electronic presentation

Updated on 09 April 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 06 August 2008

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to the date of revision of the text

Updated on 27 May 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 of SPC
 
Update to excipients listing in section 2

Updated on 01 March 2007

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 7 - change to office address of marketing authorisation holder

Updated on 01 March 2007

Reasons for updating

  • Change to date of revision

Updated on 28 September 2005

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 May 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 May 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)